瑞贝素片

公司：诺和诺德

批准日期：2019年9月20日

治疗：2型糖尿病

Rybelsus（Semaglutide）是一种口服胰高血糖素样肽-1（GLP-1）受体激动剂，用于治疗成人2型糖尿病。

新泽西州普兰斯伯罗，2019年9月20日/prnewswire/——诺和诺德今天宣布，美国食品和药物管理局（fda）已批准瑞贝苏（semaglutide）片剂7毫克或14毫克，用于患有2型糖尿病的成年人，该片剂与饮食和运动一起可改善血糖（葡萄糖）。1瑞贝苏是第一个也是唯一一个胰高血糖素样肽-1（glp-1）类似物在一个药丸和一个新的选择为成人2型糖尿病谁没有实现他们的a1c目标，目前的抗糖尿病治疗。

2型糖尿病是一个全球性的公共卫生问题，仅在美国就有2800多万人受到影响。2尽管有现有的治疗方案，许多2型糖尿病患者的血糖管理不善，会增加发生严重糖尿病相关并发症的风险。2-3

Brigham and Women's Hospital糖尿病临床研究主任Vanita R.Aroda医学博士说：“GLP-1受体激动剂是治疗2型糖尿病患者的有效药物，但部分原因是迄今为止，它们只能作为注射疗法使用。”马萨诸塞州波士顿，临床试验研究先驱。”口服glp-1受体激动剂的可用性是一个重大的发展，初级保健提供者、专家和患者现在可能更愿意使用glp-1治疗来帮助他们实现血糖目标。”

Rybelsus的批准是基于10项先锋临床试验的结果，这些试验共有9543名参与者参加，包括Rybelsus与西他列汀、恩帕利福嗪和利拉鲁肽1.8mg.4的对照研究。在这些试验中，Rybelsus降低了A1C，并且作为次要终点，体重减轻。先驱者试验中最常见的不良反应是恶心、腹痛、腹泻、食欲减退、呕吐和便秘。各试验的不良反应类型和频率相似。1,5-7

诺和诺德公司副总裁兼美国首席医疗官托德·霍布斯说：“2型糖尿病患者应该得到更多的创新、研究和支持，帮助他们实现各自的A1C目标。”有了Rybelsus，我们就有机会扩大有效的GLP-1受体激动剂治疗的使用范围，为患有2型糖尿病的成年人提供一种口服药物，这种药物以前只能作为一种注射剂来帮助他们控制血糖。”

Rybelsus被批准每日使用一次，分为两种治疗剂量：7毫克和14毫克，并将于2019年第四季度在美国上市。Rybelsus的初始供应将来自丹麦的制造设施；然而，Rybelsus的未来供应将来自美国的制造设施。2015年，诺和诺德进行了战略投资，在克莱顿建立了一个新的制造设施，北卡罗来纳州为未来对瑞贝苏的需求做准备。此外，今年早些时候，诺和诺德在北卡罗来纳州达勒姆市收购了一家桌布和包装工厂，以满足对瑞贝苏的预期供应需求。

诺和诺德正在与医疗保险供应商合作，以确保广泛的保险范围和患者获得产品。一个储蓄卡计划将在启动时提供给符合条件的商业保险患者，以保持现金支付成本低至每月10美元。

美国食品和药物管理局仍在审查诺和诺德（Novo Nordisk）针对瑞贝卢斯的新药申请（NDA），寻求降低心脏病发作、中风等主要心血管不良事件（MACE）风险的额外适应症。或成人2型糖尿病合并心血管疾病（CVD）的心血管死亡。预计将在2020年第一季度做出决定。

目前，包括欧洲药品管理局和日本药品和医疗器械管理局在内的全球多个监管机构正在对Rybelsus进行审查。

什么是Rybelsus？

Rybelsus（Semaglutide）片7毫克或14毫克是一种治疗成人2型糖尿病的处方药，与饮食和运动一起可以改善血糖（葡萄糖）。

•Rybelsus不推荐作为治疗糖尿病的首选药物

•目前尚不清楚rybelsus是否可用于胰腺炎患者。

•Rybelsus不适用于1型糖尿病患者和糖尿病酮症酸中毒患者

•不知道Rybelsus对18岁以下儿童是否安全有效

重要安全信息

关于瑞贝苏，我应该知道的最重要的信息是什么？

Rybelsus可能导致严重的副作用，包括：

•可能的甲状腺肿瘤，包括癌症。如果你的脖子有肿块或肿胀、声音嘶哑、吞咽困难或呼吸急促，请告诉你的医疗保健提供者。这些可能是甲状腺癌的症状。在对啮齿动物、恒河猴和类似于恒河猴的药物的研究中，导致甲状腺肿瘤，包括甲状腺癌。目前尚不清楚瑞贝苏是否会导致甲状腺肿瘤或一种甲状腺癌，称为甲状腺髓样癌（mtc）。

如果出现以下情况，请勿使用Rybelsus：

•您或您的任何一个家庭曾经患有MTC，或者您患有内分泌系统疾病，称为2型多发性内分泌肿瘤综合征（男性2）

•您对瑞贝苏的Semaglutide或任何成分过敏

在使用Rybelsus之前，如果您有任何其他医疗条件，请告知您的医疗保健提供者，包括如果您：

•胰腺或肾脏有问题

•有糖尿病相关视力问题的病史

•怀孕或计划怀孕。目前还不知道瑞贝苏是否会伤害到你未出生的孩子。你应该在计划怀孕前2个月停止使用Rybelsus。如果你计划怀孕或怀孕期间，与你的医疗保健提供者讨论控制血糖的最佳方法

•正在母乳喂养或计划母乳喂养。在使用Rybelsus治疗期间，不建议母乳喂养。

告诉你的医疗保健提供者你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。Rybelsus可能会影响某些药物的工作方式，而某些药物可能会影响Rybelsus的工作方式。

我该怎么用瑞贝苏？

•完全按照您的医疗保健提供者的指示服用Rybelsus

•当你第一次醒来喝一小口白开水（不超过4盎司）时，空腹口服Rybelsus。

•不要劈开、挤压或咀嚼。吞下整个瑞贝苏

•30分钟后，您可以吃、喝或服用其他口服药物。如果你吃了30到60分钟后再吃，Rybelsus效果最好

•如果你错过了一剂Rybelsus，跳过错过的剂量，回到你的常规计划

Rybelsus可能有什么副作用？

Rybelsus可能导致严重的副作用，包括：

•胰腺炎症（胰腺炎）。如果您的胃部（腹部）有严重疼痛，无论是否呕吐，都不会消失，请立即停止使用Rybelsus并致电您的医疗服务提供商。你可能会感到从腹部到背部的疼痛

•视力变化。告诉你的医疗保健提供者，如果你在治疗期间视力有变化

•低血糖（低血糖）。如果你使用另一种可能导致低血糖的药物，如磺脲类药物或胰岛素，那么你患低血糖的风险可能会更高。低血糖的症状和体征可能包括：头晕或头昏眼花、视力模糊、焦虑、易怒或情绪变化、出汗、言语含糊、饥饿、困惑或困倦、颤抖、虚弱、头痛、心跳加快和感觉紧张。

•肾脏问题（肾衰竭）。在有肾脏问题的人中，腹泻、恶心和呕吐可能导致体液流失（脱水），这可能导致肾脏问题恶化。喝水有助于减少脱水的机会，这对你很重要

•严重过敏反应。如果你有任何严重过敏反应的症状，包括发痒、皮疹或呼吸困难，请停止使用Rybelsus并立即就医。

Rybelsus最常见的副作用可能包括恶心、胃（腹）痛、腹泻、食欲下降、呕吐和便秘。恶心，呕吐和腹泻是最常见的时候，你第一次开始Rybelsus。

关于Rybelsus

瑞贝苏（Semaglutide）片（7毫克或14毫克）是天然产生的胰高血糖素样肽-1（GLP-1）的类似物。Rybelsus是药丸中第一个也是唯一一个GLP-1受体激动剂（RA）。每日一次，批准分为两种治疗剂量：7毫克和14毫克。

关于诺和诺德

诺和诺德是一家全球性的医疗保健公司，它一直在研发创新药物，帮助糖尿病患者延长健康的寿命，已经95年了。这一传统给了我们经验和能力，也使我们能够帮助人们战胜其他严重疾病，包括肥胖症、血友病和生长障碍。我们坚信，取得持久成功的方法是保持专注、长期思考，并以对经济、社会和环境负责的方式开展业务。诺和诺德在美国新泽西州设有总部，在六个州设有生产和研究设施，在全国拥有近6000名员工。有关更多信息，请访问novonordisk.us、facebook、instagram和twitter。

PLAINSBORO, N.J., Sept. 20, 2019 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).1 Rybelsus is the first and only glucagon-like peptide-1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not achieving their A1C goal with current antidiabetic treatment.

Type 2 diabetes is a global public health issue that impacts more than 28 million people in the U.S. alone.2 Despite existing treatment options, many adults with type 2 diabetes have poorly managed blood sugar that can increase the risk of developing serious diabetes-related complications.2-3

"GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment," said Vanita R. Aroda, MD, Director of Diabetes Clinical Research, Brigham and Women's Hospital, Boston, MA and a PIONEER clinical trial investigator. "The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals."

The approval of Rybelsus is based on results from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg.4 In the trials, Rybelsus reduced A1C and, as a secondary endpoint, showed reductions in body weight. The most common adverse reactions in the PIONEER trials, reported in ≥5% of patients, were nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. The types and frequency of the adverse reactions were similar across trials.1,5-7

"People living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual A1C goals," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "With Rybelsus, we have the opportunity to expand use of effective GLP-1 receptor agonist therapy by providing adults with type 2 diabetes an oral medication which was previously only available as an injection to help with managing their blood sugar."

Rybelsus is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg, and will be available in the U.S. beginning in Q4 2019. Initial supply of Rybelsus will come from manufacturing facilities in Denmark; however, future supply for Rybelsus will come from manufacturing facilities in the U.S. In 2015, Novo Nordisk made a strategic investment to build a new manufacturing facility in Clayton, NC to prepare for the future demand for Rybelsus. Additionally, earlier this year Novo Nordisk acquired a tableting and packaging facility in Durham, NC to meet anticipated supply needs for Rybelsus.

Novo Nordisk is working with health insurance providers with a goal of ensuring broad insurance coverage and patient access to the product. A savings card program will be available at the time of launch for eligible commercially-insured patients to keep out of pocket costs down to as little as $10 a month.

The U.S. FDA is still reviewing Novo Nordisk's new drug application (NDA) for Rybelsus seeking an additional indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (CVD). A decision is expected in Q1 2020.

Rybelsus is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

What is Rybelsus?

Rybelsus (semaglutide) tablets 7 mg or 14 mg is a prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).

· Rybelsus is not recommended as the first choice of medicine for treating diabetes

· It is not known if Rybelsus can be used in people who have had pancreatitis

· Rybelsus is not for use in people with type 1 diabetes and people with diabetic ketoacidosis

· It is not known if Rybelsus is safe and effective for use in children under 18 years of age

Important Safety Information

What is the most important information I should know about Rybelsus?

Rybelsus may cause serious side effects, including:

· Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Rybelsus and medicines that work like Rybelsus caused thyroid tumors, including thyroid cancer. It is not known if Rybelsus will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Rybelsus if:

· you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

· you are allergic to semaglutide or any of the ingredients in Rybelsus

Before using Rybelsus, tell your healthcare provider if you have any other medical conditions, including if you:

· have or have had problems with your pancreas or kidneys

· have a history of vision problems related to your diabetes

· are pregnant or plan to become pregnant. It is not known if Rybelsus will harm your unborn baby. You should stop using Rybelsus 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant

· are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Rybelsus.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rybelsus may affect the way some medicines work and some medicines may affect the way Rybelsus works.

How should I take Rybelsus?

· Take Rybelsus exactly as your healthcare provider tells you to

· Take Rybelsus by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)

· Do not split, crush, or chew. Swallow Rybelsus whole

· After 30 minutes, you can eat, drink, or take other oral medications. Rybelsus works best if you eat 30 to 60 minutes after taking it

· If you miss a dose of Rybelsus, skip the missed dose and go back to your regular schedule

What are the possible side effects of Rybelsus?

Rybelsus may cause serious side effects, including:

· inflammation of your pancreas (pancreatitis). Stop using Rybelsus and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back

· changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Rybelsus

· low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Rybelsus with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery

· kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration

· serious allergic reactions. Stop using Rybelsus and get medical help right away, if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing

The most common side effects of Rybelsus may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start Rybelsus.

About Rybelsus

Rybelsus (semaglutide) tablets 7 mg or 14 mg is an analog of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). Rybelsus is the first and only GLP-1 receptor agonist (RA) in a pill. It is administered once daily and is approved for use in two therapeutic doses: 7 mg and 14 mg.

About Novo Nordisk 

Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.

References       

1. Rybelsus® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.

2. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed September 2019.

3. Carls G, Huynh J, Tuttle E, Yee J, Edelman S. Achievement of Glycated Hemoglobin Goals in the US Remains Unchanged Through 2014. Diabetes Ther. 2017;8:863–873.

4. Novo Nordisk. Novo Nordisk files for US FDA approval of oral semaglutide for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes. Available at: https://www.novonordisk-us.com/media/news-releases.html?122958. Accessed September 2019.

5. Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: The PIONEER 3 randomized clinical trial. JAMA. 2019;321(15):1466-1480.

6. Rodbard H, Rosenstock J, Canani L, et al. Oral Semaglutide versus Empagliflozin in Patients with Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial. Diabetes Care. Available at: https://care.diabetesjournals.org/content/early/2019/09/13/dc19-0883. Accessed September 2019.

7. Pratley R, Amod A, Hoff ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): A randomised, double-blind, phase 3a trial. Lancet. 394(10192):39-50.

SOURCE Novo Nordisk

Posted: September 2019